Steerable access sheath and methods of use

ABSTRACT

The present invention provides devices, systems, methods and kits for endoscopically accessing a body cavity and providing a directed pathway toward a target tissue within the cavity. The directed pathway is provided by an access sheath which is positioned in a desired configuration, generally directed toward the target tissue. Depending on the location of the target tissue and the desired angle of approach, the access sheath may be required to maintain one or more curves in one or more planes to properly direct the interventional devices. In addition, the access sheath has a locking feature to hold the sheath in place and maintain the desired configuration. Interventional devices may then be passed through the sheath to the target tissue.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a divisional of, and claims the benefit of priorityfrom co-pending U.S. patent application Ser. No. 10/441,753, filed May19, 2003, (Attorney Docket No. 020489-001200US), which is acontinuation-in-part of, and claims the benefit of priority fromco-pending U.S. patent application Ser. No. 09/894,463, filed Jun. 27,2001, which is a continuation-in-part of co-pending U.S. patentapplication Ser. No. 09/544,930, filed Apr. 7, 2000, which claims thebenefit of prior Provisional Application No. 60/128,690, filed on Apr.9, 1999 under 37 CFR § 1.78(a), the full disclosures of which are herebyincorporated herein by reference. This application is related to U.S.patent application Ser. No. 10/441,531 (Attorney Docket No.020489-001400US), U.S. patent application Ser. No. 10/441,508 (AttorneyDocket No. 020489-001500US), and U.S. patent application Ser. No.10/441,687 (Attorney Docket No. 020489-001700US), all of which are filedon the same day as the instant application, the full disclosures ofwhich are incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to an access sheath for endoluminallyaccessing a body cavity and directing the passage of interventionaldevices therethrough into the cavity. Particularly, the presentinvention relates to an articulatable access sheath which directs theinterventional devices into the cavity in a desired orientation. In someembodiments, the present invention relates to vascularly accessing anatrium of the heart to direct an interventional catheter toward acardiac valve.

To access a target location within the human body from a remotelocation, a catheter is typically passed through one or more bodylumens, such as through the vascular system, to the target location.When the vascular system is used, a guidewire and dilator is insertedinto an artery or vein through a relatively small incision in thepatient's body. The guidewire and dilator is then threaded through thepatient's vasculature to reach the desired target area. Often thedilator is covered by a sheath which is passed with the dilator to thetarget location. The dilator is then removed and the sheath is used as aconduit for access for a variety of medical devices to access the targetlocation. Such devices may include catheters, surgical instruments,fiber optic cables for visualization, lasers, electronic devices, orsensors capable of monitoring physiological parameters in situ, to namea few. Although such access reduces the need for traditional invasivesurgery, challenges arise related to control, manipulation, andpositioning of instruments near the target location, particularly withina target body cavity.

A device advanced to the cavity will typically protrude into the cavityat the angle in which it entered. If the target tissue is not withinthis pathway, the device will need to be steered toward the targettissue. If more than one device is used during a procedure, each devicewill need to be steered and repositioned when used. This increases thetime and cost of the procedure and also the risk of misalignment.

For example, to gain access to the left atrium of the heart, thecatheter and/or access sheath may be tracked from a puncture in thefemoral vein, through the inferior vena cava, into the right atrium andthrough a puncture in the intra-atrial septum to the left atrium. Thispathway may then be used to access the mitral valve which lies betweenthe left atrium and the left ventricle. From the point of entry throughthe septum, the mitral valve may be located below and to the right orleft requiring the devices which are inserted to be directed downwardand perhaps laterally after entry, toward the mitral valve. In addition,devices used for applying interventional therapies to the mitral valvemay require precise alignment with the valve commissures, leaflets, orcoaptation line to perform the procedure. When such procedures requirethe use of more than one instrument, each instrument would be dependentupon proper positioning in relation to the valve. This would requirethat positioning or steering mechanisms be built into each instrumentand each instrument would be required to be properly positioned whenintroduced. This adds cost, complexity, and time to the overallprocedure.

To overcome some of these challenges, access sheaths have been developedto direct instruments that are passed therethrough. For example, anaccess sheath having a pre-shaped curve at its distal end has beendeveloped to both assist in negotiating twists and branches common in apatient's arterial or venous system and to maintain a shape oncepositioned within a target cavity. Since the pre-shaped curve is fixedinto the access sheath at the time of manufacture, the radius and extentof the curvature generally cannot be altered. Due to anatomicalvariations, extensive pre-surgical planning would be necessary todetermine the correct curvature of the access sheath. Such tailoringwould be prohibitively complex and a predicted curvature would mostlikely still require additional repositioning once inside the body.Continuously replacing the pre-shaped access catheter in hopes ofobtaining the proper curvature would be expensive and time consuming,possibly placing the patient at additional risk.

Steerable guide catheters and delivery catheters have been developed tomore effectively navigate through the tortuous pathways of some bodylumens, particularly the vascular system. Typically steering isaccomplished through a combination of torqueing the proximal end of thecatheter and pulling various pullwires to deflect the distal end of thecatheter. Unfortunately, torque transmission has not been perfected insuch steerable catheters. Due to the length of the catheter body betweena proximal control end and the distal tip, torsion can tend toaccumulate as the proximal end of the catheter is twisted to rotate thetip. The accumulated torsional moment may release unevenly, resulting inskipping or rapid rotation of the distal tip inside the vessel. Tooptimize torque transmission, the walls of such steerable cathetersgenerally comprise a series of layers. In a typical steerable catheter,a woven metal or polymeric tubular braid may be sandwiched between aninner tubular sleeve and an outer tubular jacket. As a consequence,improved torquability generally results in increased wall thickness,which in turn increases the outside diameter of the steerable catheteror reduces any given desired inside diameter. In addition, such a heavybraided construction is often difficult to deflect by actuation ofpullwires. To overcome this, the deflectable section can be softenedwith coils or softer polymers to allow it to be deflected to a muchgreater extent. However, this reduces the catheter's ability to transmittorque to or through this softer section. In addition, these softersections may not offer adequate support for interventional devices ortools which are later passed through its inner lumen.

For these reasons, it would be desirable to provide an access sheathhaving an articulatable distal end which does not rely on permanentpre-shaping or torque transmission for positioning the access sheathwithin a target body cavity in a desired orientation. The articulatableaccess sheath should have a large lumen diameter to accommodate thepassage of a variety of interventional devices, should have good wallstrength to avoid kinking or collapse of the sheath when bent aroundtight curves, and should have good column and tensile strength to avoiddeformation when the interventional devices are passed through thelumen. The sheath articulation mechanisms should provide for a highdegree of controlled deflection at the distal end of the sheath butshould not take up significant lumen area to allow for passage ofinterventional devices. Further, the access sheath should bearticulatable in a manner which allows compound curves to be formed, forexample curvature within more than one plane. Such manipulation shouldallow fine control over the distal end to accommodate anatomicalvariations within the same type of body cavity and for use in differenttypes of body cavities.

2. Description of the Background Art

Hermann et al. (U.S. Pat. No. 5,843,031) describes a large-diameterintroducer sheath having a hemostasis valve and a removable steeringmechanism. The steering mechanism is described to be within an obturatorwhich is positioned within the sheath during positioning and is thenremovable. Adair (U.S. Pat. No. 5,325,845) describes a steerable sheathhaving an articulatable member which is deformable to allowarticulation. Kordis (U.S. Pat. No. 5,636,634) describes a sheath whichis positioned by a separate, dedicated steering catheter.

A number of the other references refer to guidewires or catheters whichthemselves are steerable by means of wires. For example, Stevens-Wrightet al. (U.S. Pat. No. 5,462,527) describes a handle which appliestension selectively to two or four pull cables to steer an attachedcatheter. Stevens-Wright et al. (U.S. Pat. No. 5,715,817) furtherdescribes improvements in actuating the tip of the catheter described inStevens-Wright et al. '527.

Hammerslag (U.S. Pat. No. 5,108,368) describes a steerable guidewire orcatheter wherein the tip is deflectable through a full 360 degree rangeof motion by means of axially moveable deflection wires extendingthroughout. Hammerslag (U.S. Pat. No. 5,820,592) describes a guidecatheter through which a torque control wire or a deflection wireextends. Manipulating an actuator controls the wire to steer or aim theguide catheter. Savage (U.S. Pat. No. 5,368,564) and Savage et al. (U.S.Pat. No. 5,507,725) also describe a steerable catheter having wiremembers extending through the catheter wall to manipulate the tip.

Likewise, the following also provide variations of the steerablecatheters which utilize wires for manipulation: Accisano, III (U.S. Pat.No. 5,571,085), Krauter (U.S. Pat. No. 5,359,994), West et al. (U.S.Pat. No. 5,318,525), Nardeo (Pub. No. US 2001/0037084 A1), Bumbalough(U.S. Pat. No. 6,267,746), Webster, Jr. (U.S. Pat. No. 6,123,699),Lundquist et al. (U.S. Pat. No. 5,195,968) and Lundquist et al. (U.S.Pat. No. 6,033,378). Falwell et al. (U.S. Pat. No. 6,319,250) describesa catheter having any suitable steering mechanism known in the art.

BRIEF SUMMARY OF THE INVENTION

The present invention provides devices, systems, methods and kits forendoscopically accessing a body cavity and providing a directed pathwaytoward a target tissue within the cavity. The directed pathway isprovided by an access sheath which is positioned in a desiredconfiguration, generally directed toward the target tissue.Interventional devices may then be passed through the sheath to thetarget tissue. Depending on the location of the target tissue and thedesired angle of approach, the access sheath may be required to maintainone or more curves in one or more planes to properly direct theinterventional devices. The access sheath of the present invention has aportion which comprises a series of articulating members to allow thesheath to form these curvatures. In addition, the access sheath has alocking feature to hold the articulating members in place and maintainthe desired configuration. The articulating members may be positioned byan articulating mechanism within the sheath, such as pullwires whichextend through at least one of the articulating members. Or, anarticulatable obturator may be positioned within the sheath, whereinarticulation of the obturator in turn moves the encasing sheath into thedesired articulated position. The obturator is then removed and thesheath remains in the articulated position. Thus, the present inventionallows the target tissue to be repeatedly accessed through the accesssheath without the need to incorporate steering mechanisms into eachinterventional device or the need to spend additional time repositioningeach interventional device upon use.

In a first aspect of the present invention, an articulatable accesssheath is provided for accessing the body cavity. The access sheathcomprises a shaft having a proximal end, a distal end and a centrallumen therethrough. The distal end is sized appropriately for theintended method of approaching the body cavity. The body cavity may beapproached laparoscopically, thorascopically, endoscopically,endovascularly, percutaneously or by any suitable method. Preferably,the distal end of the access sheath is passable through a body lumen,such as a blood vessel within the vascular system. This is particularlythe case when approaching a chamber of the heart, which can be accessedeither through the femoral vein and inferior vena cava or the superiorvena cava into the right atrium, or through a femoral or axillary arteryand the aorta into the left ventricle. The distal end may further beconfigured to penetrate the interatrial septum so as to be passed fromthe right atrium to the left atrium. Other body lumens through which thedevice may be positioned include the esophagus for approaching thestomach, the colon for approaching the gastrointestinal system, thetrachea for approaching the lungs, or the urethra for approaching theurinary tract. In other instances, the distal end of the access sheathis passable directly through body tissues, such as in a direct accessprocedure to the heart. The access sheath may be positioned in apenetration in the chest wall and used to access the outside of theheart to perform diagnostic and interventional procedures such asablation of the pulmonary veins to treat atrial fibrillation.Alternatively, the sheath may be passed through the wall of the heart toaccess the interior chambers thereof. The central lumen extends throughthe length of the shaft and is sized for passage of an interventionaldevice, such as a catheter or tool, to perform procedures such as valverepair, electrophysiological mapping and ablation, and septal defectrepair. To accommodate a variety of interventional devices, the centrallumen is generally relatively large in comparison to the total crosssection of the shaft.

The shaft also includes a portion which comprises a series ofarticulating members. The articulating members may have any suitableshape, however in preferred embodiments the members compriseinterfitting domed rings. The ring aspect provides a hollow interiorwhich forms the central lumen. The dome aspect provides a surface whichis rotatable against an interfitting surface of an adjacent domed ring.Since the domed rings are individually rotatable, the series ofarticulating members can be positioned in a variety of arrangements tofollow any pathway. Typically, the portion of the shaft comprising theseries of articulating members is the distal end. This is because thedistal end is usually advanced into the body cavity and benefits fromarticulation to properly direct interventional devices which are passedthrough. However, it may be appreciated that the articulating portionmay be disposed at any location along the shaft and more than oneportion having a series of articulating members may be present.

In some embodiments, the sheath includes at least one pullwire toarticulate the articulating members. The pullwires extend through atleast one of the articulating members to move the portion of the shafthaving the articulating members into an articulated position. Thepullwires can extend through the central lumen or through individuallumens in the walls of the articulating members. It may be appreciatedthat more than one pullwire may extend through any given lumen. Toprovide optimal positioning of the shaft, a plurality of pullwires arepresent at locations around the perimeter of the central lumen. Thepresence of each pullwire allows articulation of the shaft in thedirection of the pullwire. For example, when pulling or applying tensionto a pullwire extending along one side of the shaft, the shaft willbend, arc or form a curvature toward that side. To then straighten theshaft, the tension may be relieved for recoiling effects or tension maybe applied to a pullwire extending along the opposite side of the shaft.Therefore, pullwires can be symmetrically placed along the sides of theshaft. Although any number of pullwires are possible, generally, four toeight pullwires are preferred.

Each pullwire is attached to the shaft at a location chosen to result inparticular curvature of the shaft when tension is applied to thepullwire. For example, if a pullwire is attached to the most distalarticulating member in the series, applying tension to the pullwire willcompress the articulating members proximal to the attachment point alongthe path of the pullwire. This results in a curvature forming in thedirection of the pullwire proximal to the attachment point. It may beappreciated that the pullwires may be attached to any location along theshaft and is not limited to attachment to articulating members.

When more than one curvature is desired, pullwires are attached atvarious attachment points, each attachment point providing a differentcurvature or altering the overall articulated position of the sheath.For example, when a first pullwire is fixedly attached to the shaft at aprimary attachment point, applying tension to the first pullwire arcsthe series of articulating members proximal to the primary attachmentpoint to form a primary curve. If the distal end terminates in a distaltip and the primary attachment point is located at the distal tip, theprimary curve will extend through the entire series of articulatingmembers. If the primary attachment point is located mid-way along theseries of articulating members, the primary curve will extend throughthe series of articulating members proximal to the primary attachmentpoint. When a second pullwire is fixedly attached to the shaft at asecondary attachment point, applying tension to the second pullwire arcsthe series of articulating members proximal to the secondary attachmentpoint to form a secondary curve. The primary and secondary curves maylie in the same plane or in different planes. In some embodiments, theplanes are substantially orthogonal.

In some embodiments, a third pullwire is fixedly attached to the shaftat a distal attachment point and applying tension to the third pullwiremoves the distal end through an angle theta. In particular, when thedistal attachment point is located near the distal tip, the thirdpullwire moves the distal tip through the angle theta. The angle thetawill be described and illustrated in more detail in later sections.However, the angle theta generally serves to tip or angle the distal tipin relation to a center line to further refine the articulated positionof the sheath. Often the angle theta lies in a plane which is differentfrom at least the primary curve or the secondary curve and sometimesboth. In fact, the angle theta may lie in a plane which is orthogonal toboth the primary curve and the secondary curve.

Tension is applied to the pullwires by manipulation of actuators locatedon a handle. The handle is connected with the proximal end of thearticulatable access sheath and remains outside of the body. Theactuators may have any suitable form, including buttons, levers, knobs,switches, toggles, dials, or thumbwheels, to name a few. Each actuatormay apply tension to an individual pullwire or to a set of pullwires, ormay actuate the articulation element according to its type. Generally, adifferent actuator is used to form each curvature, such as the primarycurvature and secondary curvature, and to cause movement through theangle theta. The handle may also include a locking actuator to actuate alocking mechanism.

Locking holds the articulating members in the articulated position. Bysuch locking, the sheath is maintained in the articulated position whileinterventional devices are passed therethrough. The sheath will retainsufficient rigidity to deflect and guide a non-steerable interventionaldevice through its central lumen and direct the device to the bodycavity, particularly to the target tissue within the body cavity. Insome embodiments, the locking feature comprises sufficient frictionbetween articulating members so that the members are held in place,either by friction of one articulating member against another or by thepresence of frictional elements between the articulating members. Inother embodiments, the locking feature comprises a locking mechanismwhich includes a mechanism for holding at least one of the pullwires inthe tensioned position. As described previously, tensioning of apullwire typically draws a portion of the articulating members together,forming a curve. By holding the pullwire in this tensioned position, thearticulated members can often maintain this arrangement. By holding morepullwires in place, the ability to maintain the arrangement isincreased. Therefore, some locking mechanisms will hold all of thepullwires in a tensioned position. When individual pullwires controlindividual portions of the series of articulated members, the portionsmay be individually locked by holding tension in the appropriatepullwires. This may be useful, for example, when a desired primary curveis established and a secondary curve is undertaken. The primary curvemay be locked in place prior to creating the secondary curve to allowindependent creation of each curve.

Although only a few types of curves have been described in relation tothe articulated position, it may be appreciated that any number ofcurves or shapes may be formed throughout the series of articulatingmembers. In addition, permanent curves may also be provided throughoutthe portion of the shaft comprising the series of articulating members.Such permanent curves may be a result of the shapes of the articulatingmembers, the way in which the articulating members are arranged or fittogether, or of any other mechanism. Further, any number of curves orshapes may be pre-formed throughout portions of the shaft other than theportion of the shaft comprising the series of articulating members. And,alternative articulation elements may also be used, such as pushrods,thermally-controlled shape memory alloy wires, or hydraulic or pneumaticfluids, to name a few.

In a second aspect of the present invention, an access system foraccessing a body cavity is provided. The access system comprises asheath which includes a shaft having a proximal end, a distal end and acentral lumen therethrough. Again, the distal end is sized appropriatelyfor the intended method of approaching the body cavity. And, a portionof the shaft comprises a series of articulating members which arelockable in a fixed position. The access system further comprises anobturator sized for passage through the central lumen and having meansfor articulating the obturator. Articulation of the obturator positionsthe articulating members of the sheath in an articulated position whichbecomes the fixed position upon locking. The obturator is then removedso that interventional devices may be passed therethrough.

The portion of the shaft comprising the series of articulating membersmay be the same or similar to that described above in relation to thearticulatable access sheath. Again, in preferred embodiments thearticulating members comprise interfitting domed rings, each domed ringindependently rotatable against an adjacent domed ring. And, pullwiresmay be present which pass through the at least one of the articulatingmembers. However, in this embodiment, the pullwires are not used toposition the articulating members, rather the pullwires are used to lockthe articulating members in the fixed position. In some embodiments, thepullwires hold the articulating members in contact with enoughfrictional force to hold or lock the articulating members in the fixedposition. In other embodiments, tension may be applied to some or all ofthe pullwires to further wedge the articulating members together andtherefore lock them in place.

The articulating members are moved into the articulated position byaction of the obturator. Once the obturator has been placed within thecentral lumen of the shaft, the obturator can be moved into anyarrangement. For example, the obturator may be shaped to have bends,arcs, curves or angles. Such shaping can be achieved by any suitablemechanism, including pullwires which act similarly to those describedabove in relation to articulating the articulatable access sheath. Theshaping of the obturator applies forces to the central lumen andtransfers the shaping to the surrounding sheath. Again, the articulatedposition can include any number of curves, including a primary curve,secondary curve or angle theta, to name a few. And, the curves may liein the same or different planes.

Articulation of the obturator can be achieved by manipulation ofactuators located on an obturator handle. The obturator handle isconnected with the proximal end of the obturator and remains outside ofthe body. Again, the actuators may have any suitable form, includingbuttons, knobs, switches, toggles, dials, or thumbwheels, to name a few.Each actuator may apply tension to an individual pullwire or to a set ofpullwires. Generally, a different actuator is used to form eachcurvature, such as the primary curvature and secondary curvature, and tocause movement through the angle theta. The obturator handle may alsoinclude an obturator locking actuator to actuate an obturator lockingmechanism.

The obturator locking mechanism locks the obturator in the articulatedposition. By such locking, the obturator is maintained in thearticulated position while the sheath is then locked in position. Insome embodiments, the locking mechanism of both the obturator and sheathinclude a mechanism for holding at least one of the pullwires in thetensioned position. Some locking mechanisms will hold all of thepullwires in a tensioned position. When individual pullwires affectindividual portions of the obturator or the series of articulatedmembers, the portions may be individually locked by holding tension inthe appropriate pullwires.

Again, although only a few types of curves have been described inrelation to the articulated position, it may be appreciated that anynumber of curves or shapes may be formed throughout the obturator. Inaddition, permanent curves may also be pre-set throughout obturator,such as by heat-setting. These permanent curves will then also betransferred to the surrounding sheath.

After the sheath has been locked in place, the obturator can then beunlocked and removed. Or, when the obturator has a permanent heat-setcurve, the locked sheath will be sufficiently rigid enough to allowremoval of the pre-curved obturator without changing the shape of thesheath. The sheath will also retain sufficient rigidity to deflect andguide a non-steerable interventional device through its central lumenand direct the device to the body cavity, particularly to the targettissue within the body cavity.

In other embodiments, the obturator may only form a single curve yet maybe used to form compound or multiple curves in the sheath. For example,the obturator may be positioned in a first location along the sheathforming a first curve. The sheath is then locked in place in this firstlocation to hold the first curve. The obturator may then be positionedin a second location along the sheath forming a second curve. Likewise,the sheath is then locked in the second location to hold the secondcurve. Hence, multiple or compound curves may be formed from anobturator capable of forming a single curve. This concept may beextrapolated to cover obturators capable of forming more than a singlecurve yet are used to form curves in sheath which are more complex or ofa higher number.

In a third aspect of the present invention, methods of accessing a bodycavity are provided. In one embodiment, the method includes advancing asheath through a body lumen to the body cavity, wherein the sheathincludes a shaft having a proximal end, a distal end, a central lumentherethrough, and a portion of the shaft comprises a series ofarticulating members. Although the sheath can be used to access any bodycavity through any pathway, such as laparoscopically, thorascopically,endoscopically, endovascularly or percutaneously, the sheath mayparticularly be used to access one or more chambers of the heart. Thechambers of the heart provide access to many tissues which may betargeted for treatment, such as valves, chordae tendinae, papillarymuscles, the Purkinje system, pulmonary veins and coronary arteries, toname a few. When targeting the mitral valve, the left atrium may beaccessed to approach the valve from above. To accomplish this, thesheath may be advanced through the vasculature to the right atrium andpassed through the intra-atrial septum to the left atrium. Thearticulating members are then articulated to move the portion of theshaft comprising the series of articulating members into an articulatedposition. It may be appreciated that the mitral valve may alternativelybe approached from below or from the ventricular side by accessing theleft ventricle. This is typically achieved by advancing the sheaththrough the vasculature to the aorta, through the aortic valve and intothe left ventricle. Examples of this approach and other approach methodsare provided in U.S. patent application Ser. No. 09/894,463 (AttorneyDocket No. 020489-000400US) filed on Jun. 27, 2001 incorporated byreference herein for all purposes. In a further alternative approach,the access sheath may be positioned through a surgical penetration inthe chest wall and through a penetration in a wall of the heart toaccess the cardiac chambers. Preferably, for mitral valve and otherprocedures in the left side of the heart, the access sheath isintroduced into the right atrium and then advanced across theinteratrial septum into the left atrium.

As described previously, the articulated position may include any numberof curves or shapes to properly direct the sheath toward the targettissue. When targeting the mitral valve via the right atrium, the distalend of the sheath extends into the open space of the right atrium. Todirect the distal tip of the sheath toward the mitral valve, the sheathmay be articulated to move the distal tip laterally, vertically, orangularly, to name a few. For example, the articulated position mayinclude a primary curve in a primary plane parallel to the valvesurface. This moves the distal tip laterally in relation to the valve.The articulated position may further include a secondary curve in asecondary plane; typically the secondary plane is different from theprimary plane and optionally substantially orthogonal to the primaryplane. This moves the distal tip vertically and angularly, directing thecentral lumen toward or away from the valve along the secondary plane.In addition to these or additional curves, the articulated position mayfurther include an angle theta. This moves the distal end vertically andangularly through a plane which differs from the secondary plane.Consequently, the central lumen can be directed toward or away from thevalve along a theta plane which is different than the secondary planeand optionally the primary plane.

Articulating the articulating members may be accomplished by any of themeans described above. For example, the sheath may further comprise atleast one pullwire which extends through at least one of thearticulating members. Applying tension to the at least one pullwirewould thus articulate the articulating members. Once the articulatingmembers are moved into a desired articulated position, the articulatingmembers are locked in place. Locking the articulating members maycomprise holding the tension in the at least one pullwire with a lockingmechanism. As described previously, locking may be accomplished byholding tension in all of the pullwires.

Once the sheath is locked in the articulated position, interventionaldevices are then passed through the central lumen, wherein thearticulated position directs the interventional device into the bodycavity. In this example, an interventional catheter or tool is passedthrough the central lumen into the left atrium and directed toward themitral valve. Depending on the direction provided by the sheath, theinterventional device may optionally be advanced through the valve,between the leaflets. The desired surgical procedure can then beperformed. If additional catheters or tools are needed, the devices mayeasily be interchanged by removing one and advancing another while thesheath remains in the articulated position.

In another embodiment, the method includes advancing a sheath through abody lumen to a body cavity, wherein the sheath comprises a shaft havinga proximal end, a distal end, a central lumen therethrough and a portionof the shaft comprises a series of articulating members. However, inembodiment the method includes passing an obturator through the centrallumen and articulating the obturator to position the articulatingmembers in an articulated position. The obturator may be articulated byany of the means described previously. The articulated members are thenlocked in the articulated position and the obturator is removed to allowpassage of an interventional device through the central lumen, whereinthe articulated position directs the device into the body cavity.

In a fourth aspect of the present invention, the devices, systems andmethods of the present invention may be provided in one or more kits forsuch use. The kits may comprise an access sheath and instructions foruse. The access sheath may be articulatable by means of mechanismsincorporated in the sheath, or the kit may include an articulatableobturator for use in articulating the sheath. Optionally, such kits mayfurther include any of the other system components described in relationto the present invention and any other materials or items relevant tothe present invention.

Other objects and advantages of the present invention will becomeapparent from the detailed description to follow, together with theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an embodiment of an articulatable accesssheath of the present invention.

FIGS. 2A-2D illustrate examples of articulated positions of the accesssheath.

FIG. 3 is a perspective side view of an access sheath having anadditional curve compared to the articulated positions shown in FIGS.2A-2D.

FIGS. 4A-4C illustrate a method of using the access sheath for accessingthe mitral valve.

FIG. 5 is a perspective view of the portion of the sheath comprising aseries of articulating members.

FIGS. 6A-6C are side views of articulating members having differenttypes of inner surfaces.

FIGS. 7A-7D illustrate an embodiment of an articulating member whichaccommodates four pullwires.

FIGS. 8A-8D illustrate an embodiment of an articulating member whichaccommodates eight pullwires.

FIGS. 9A-9D illustrate an embodiment of an articulating member whichaccommodates eight pullwires yet has an inner surface which differs fromthe embodiment shown in FIGS. 8A-8D.

FIGS. 10A-E illustrate an embodiment of an articulating member which isdesigned to reduce possible binding of the pullwires and to increasestability of curves during articulation.

FIG. 11A illustrates various liners which comprise some embodiments ofthe access sheath.

FIG. 11B is a perspective view of an embodiment of an access sheathwherein various pullwires are attached to the shaft at variousattachment points.

FIG. 12 is a perspective view of an embodiment of an access system ofthe present invention.

FIGS. 13A-13D illustrate a method of using the access system foraccessing the mitral valve.

FIG. 14 illustrates a kit constructed in accordance with the principlesof the present invention.

DETAILED DESCRIPTION OF THE INVENTION Articulatable Access Sheath

Referring to FIG. 1, an embodiment of an articulatable access sheath 10of the present invention is illustrated. The sheath 10 comprises a shaft11 having a proximal end 12, a distal end 14, and a central lumen 16therethrough. The distal end 14 is sized to be passable through a bodylumen to a body cavity. Therefore, the distal end 14 preferably has anouter diameter in the range of approximately 0.040 in. to 0.500 in.,more preferably in the range of 0.130 in. to 0.300 in. The central lumen16 is sized for passage of an interventional device therethrough.Therefore, the central lumen 16 preferably has an inner diameter in therange of approximately 0.030 in. to 0.450 in., more preferably in therange of 0.120 in. to 0.250 in. In addition, a portion of the shaft 11is comprised of a series of articulating members 18. In this embodiment,the articulating members 18 are shown disposed at the distal end 14 ofthe shaft 11, terminating in a distal tip 15. Here, the articulatingmembers 18 extend over the distal most 1 to 10 cm of the sheath 10.However, it may be appreciated that the articulating members 18 may bedisposed at any location along the sheath. For example, if a straight ornon-articulating portion is desired near the distal end 14, thearticulating members 18 may be located at a more proximal position.

The portion of the shaft 11 having the articulating members 18 ismovable into an articulated position by actuation of one or morepositioning mechanisms. Actuation of the positioning mechanisms isachieved with the use of actuators, such as actuators 22, 24, 26 locatedon a handle 20. The handle 20 is connected to the proximal end 12 of theshaft 11 and remains outside of the patient's body during use. Actuators22, 24, 26 are used to bend, arc or reshape the portion of the shaft 11comprising articulating members 18. For example, a primary curveactuator 22 can be used to actuate one or more pull wires to form aprimary curve in the portion of the shaft 11 comprising the series ofarticulating members 18. Further, a secondary curve actuator 24 can beactuated to form a secondary curve in the portion of the shaft 11comprising the series of actuating members 18. And a theta actuator 26can be manipulated to move the distal tip 15 through an angle theta. Inaddition, a locking actuator 28 may be used to actuate a lockingmechanism to lock the articulating members 18 in the articulatedposition. Actuators 22, 24, 26, are illustrated as thumbwheels andactuator 28 is illustrated as a rotating knob. It may be appreciatedthat such actuators 22, 24, 26, 28 and any additional actuators locatedon the handle 20 may take any suitable form including knobs, buttons,levers, switches, toggles, sensors or other devices. In addition, thehandle 20 may include a numerical or graphical display of informationsuch as data indicating the articulated position of the sheath 10.

Example Articulated Positions

FIGS. 2A-2D illustrate examples of articulated positions that thearticulating members 18 of the access sheath 10 may hold. Referring toFIG. 2A, the articulating members 18 are configured to allow movementinto an articulated position which includes a primary curve 40. Theprimary curve 40 typically has a radius of curvature 42 in the range ofapproximately 0.125 in. to 1.000 in., preferably in the range ofapproximately 0.250 in. to 0.500 in. As shown, when the articulatedposition includes only a primary curve 40, the articulating members 18lie in a single plane X. An axis x, transversing through the center ofthe central lumen 16 at the distal tip 15, lies within plane X.

Referring to FIG. 2B, the articulating members 18 may further beconfigured to so that the articulated position further includes asecondary curve 46. The secondary curve 46 typically has a radius ofcurvature 48 in the range of approximately 0.050 in. to 0.750 in.,preferably in the range of approximately 0.125 in. to 0.250 in. Thesecondary curve 46 can lie in the same plane as the primary curve 40,plane X, or it can lie in a different plane, such as plane Z as shown.In this example, plane Z is substantially orthogonal to plane X. Axis z,transversing through the center of the central lumen 16 at the distaltip 15, lies within plane Z. By comparing axis x to axis z, the movementof the distal tip 15 may be compared. Adjustment of the articulatingmembers 18 to include the secondary curve 46 directs the central lumen16 downward, as shown, along axis z. In this example, axis x and axis zare at substantially 90 degree angles to each other; however, it may beappreciated that axis x and axis z may be at any angle in relation toeach other. Also, although in this example the primary curve 40 and thesecondary curve 46 lie in different planes, particularly insubstantially orthogonal planes, the curves 40, 46 may alternatively liein the same plane.

Referring now to FIG. 2C, the articulating members 18 may be furthermanipulated to allow the distal tip 15 to move through an angle theta50. The angle theta 50 is in the range of approximately −100° to +100°,preferably in the range of approximately −50° to +50°. As shown, theangle theta 50 lies within a plane Y. In particular, axis y, which runsthrough the center of the central lumen 16 at the distal tip, forms theangle theta 50 with axis z. In this example, plane Y is orthogonal toboth plane X and plane Z. Axes x, y, z all intercept at a point withinthe central lumen 16 which also coincides with the intersection ofplanes X, Y, Z.

Similarly, FIG. 2D illustrates movement of the distal tip through anangle theta 50 on the opposite side of axis z. Again, the angle theta 50is measured from the axis z to the axis y, which runs through the centerof the central lumen 16 at the distal tip 15. As shown, the angle theta50 lies in plane Y. Thus, the primary curve 40, secondary curve 46, andangle theta 50 can all lie in different planes, and optionally inorthogonal planes. However, it may be appreciated that the planes withinwhich the primary curve 40, secondary curve 46 and angle theta 50 liemay be mutually dependent and therefore would allow the possibility thatsome of these lie within the same plane.

Further, the articulating members 18 may be configured to provideadditional curves or shapes. For example, as illustrated in FIG. 3, anadditional curve 54 may be formed by the articulating members 18proximal to the primary curve 40, secondary curve 46, and angle theta50. Such additional curves 54 may be formed by the articulating members18 by manipulation of the actuators on the handle 20, or the curves 54may be permanently pre-formed. Likewise, any number of curves or shapesmay be pre-formed throughout portions of the sheath other than theportion of the sheath comprising the series of articulating members 18.In addition or alternatively, pre-formed portions may be intermixed withthe portion of the sheath comprising the series of articulating members18, such as in an alternating pattern. Thus, any number of curves may beformed in the access sheath 10 to create the articulated position.

The articulated position of the access sheath 10 illustrated in FIGS.2A-2D and FIG. 3 is particularly useful for accessing the mitral valve.FIGS. 4A-4C illustrate a method of using the access sheath 10 foraccessing the mitral valve MV. To gain access to the mitral valve, theaccess sheath 10 may be tracked from a puncture in the femoral vein,through the interior vena cava and into the right atrium. As shown inFIG. 4A, the access sheath 10 may be punctured through a fossa F in theintra-atrial septum S. The access sheath 10 is then advanced through thefossa F so that the distal tip 15 is directed over the mitral valve MV.Again, it may be appreciated that this approach serves merely as anexample and other approaches may be used, such as through the jugularvein, femoral artery, port access or direct access, to name a few.

It is then desired to move and tip the distal tip 15 so that the centrallumen 16 is directed toward the target tissue, the mitral valve MV. Inparticular, the central lumen 16 is to be directed toward a specificarea of the mitral valve MV, such as toward the opening 60 between thevalve leaflets LF, so that a particular interventional procedure may beperformed. A primary curve 40 may be formed by the series ofarticulating members 18, as described above. In this example, formationof the primary curve 40 moves the distal tip 15 within a primary plane,corresponding to previous plane X, parallel to the valve surface. Thismoves the distal tip 15 laterally along the short axis of the mitralvalve MV, and allows the distal tip 15 to be centered over the opening60. In this articulated position, any interventional devices which arepassed through the central lumen 16 would be directed horizontally overthe valve MV. To direct catheters or tools into the opening 60, it isnecessary that the distal tip 15 is pointed downward towards the mitralvalve MV.

Referring to FIG. 4B, the access sheath 10 is shown in an articulatedposition which includes a secondary curve 46 in a secondary plane,corresponding to previous plane Z. Formation of the secondary curve 46moves the distal tip 15 vertically and angularly between the commissuresC, directing the central lumen 16 toward the mitral valve MV. In thisarticulated position an interventional device which is passed throughthe central lumen 16 would be directed toward and/or through the opening60. Although the primary curve 40 and the secondary curve 46 may bevaried to accommodate different anatomical variations of the valve MVand different surgical procedures, further adjustment may be desiredbeyond these two curvatures for proper positioning of the access sheath10.

Thus, the access sheath 10 may include additional curvatures throughoutthe articulating members 18 and/or include the ability of the distal tip15 to move angularly through an angle theta 50. This moves the tipvertically and angularly through a theta plane, corresponding toprevious plane Y. Movement of the distal tip 15 through the angle theta50 in either direction is shown in dashed line in FIG. 4B. Consequently,the central lumen 16 can be directed toward the mitral valve MV within aplane which differs from the secondary plane. After such movements, theaccess sheath 10 will be in an articulated position which positions thedistal tip 15 so that the opening of the central lumen 16 at the tip 15faces the desired direction. Once the desired articulated position isachieved, the articulating members 18 are locked in place by a lockingfeature. The locking feature may simply be the articulating membersholding the desired articulated position by friction during thearticulation process. In this situation, the members are essentiallyalready locked in place. The locking feature may alternatively be alocking mechanism which is activated, such as simultaneous tensioning ofcables to compress the articulation members and locking of the cables inthis tensioned position. In any case, such locking provides stiffness inthe access sheath 10 for the passage of interventional devices 70, asillustrated in FIG. 4C. The interventional device 70 can be passedthrough the central lumen 16 toward the target tissue, in this case themitral valve MV. Positioning of the distal end 15 over the opening 60,as described above, allows the device 70 to pass through the opening 60between the leaflets LF if desired, as shown. At this point, any desiredsurgical procedure may be applied to the mitral valve for correction ofregurgitation or any other disorder.

Articulating Members

Referring to FIG. 5, a perspective view of the portion of the shaft 11comprising a series of articulating members 18 is illustrated. Eacharticulating member 18 may have any shape, particularly a shape whichallows interfitting or nesting as shown. In addition, it is desired thateach member 18 have the capability of independently rotating against anadjacent articulating member 18. In this embodiment, the articulatingmembers 18 comprise interfitting domed rings 84. The domed rings 84 eachinclude a base 88 and a dome 86. The base 88 and dome 86 have a hollowinterior which, when the domed rings 84 are interfit in a series, formsa central lumen 16. In addition, the dome 86 allows each articulatingmember 18 to mate against an inner surface of an adjacent domed ring 84.Dome 86 has a convex curvature selected to provide smooth movement andthe desired degree of articulation of adjacent domed rings 84. Thecurvature may be spherical, parabolic, or other rounded shape. Domes 86could alternatively comprises one or a series of frustoconical surfaces.Base 88 may have a cylindrical, frustoconical, dome-shaped or othersuitable external shape.

Also shown in FIG. 5, the interfitting domed rings 84 are connected byat least one pullwire 80. Such pullwires typically extend through thelength of the access sheath 10 and at least one of the interfittingdomed rings 84 to a fixation point where the pullwire 80 is fixedlyattached to the shaft 11. By applying tension to the pullwire 80, the atleast one pullwire 80 arcs the series of interfitting domed rings 84proximal to the attachment point to form a curve. Thus, pulling orapplying tension on at least one pullwire, steers or deflects the accesssheath 10 in the direction of that pullwire 80. By positioning variouspullwires 80 throughout the circumference of the domed rings 84, theaccess sheath 10 may be directed in any number of directions. Eachinterfitting domed ring 84 may comprise one or more pullwire lumens 82disposed around the periphery of each domed ring 84 through which thepullwires 80 are threaded. Alternatively, the pullwires 80 may bethreaded through the central lumen 16. In any case, the pullwires areattached to the sheath 10 at a position where a desired curve is to beformed. The pullwires 80 may be fixed in place by any suitable method,such as soldering, gluing, tying, or potting, to name a few. Suchfixation method is typically dependent upon the materials used. Thearticulating members 18 may be comprised of any suitable biocompatiblematerial including stainless steel, cobalt chromium, titanium, variousother metals, ceramics, as well as polymers or co-polymers. Likewise thepullwires 80 may be comprised of any suitable material such as fibers,polymeric monofilament or multifilament line, sutures, metal wires, ormetal braids. In a preferred embodiment, wires of Nitinol or stainlesssteel are utilized. Pull wires 80 may be coated with lubricious coatingssuch as Parylene to reduce friction. Alternatively, sheaths or eyelets(not shown) of low friction material such as Teflon may be provided inlumens 82 or central lumen 16 through which pull wires 80 extend toincrease slidability.

In addition, select portions of the articulating members 18 may be fixedtogether to create desired curves. For example, when the articulatingmembers 18 comprise domed rings 84, two, three, four or more domed rings84 positioned in a row may be fixed in their interfit positions toprevent movement or rotation between the rings 84. This may be achievedby any suitable method such as soldering, gluing, tying, or potting.Such fixing will create segments which cannot be articulated, howeverarticulating members 18 on either side of these segments may bearticulated. This may be useful in creating certain curves or shapes,particularly square shapes or sharp angles. It may also be appreciatedthat these select portions of articulating members 18 may be fixed toform either a straight segment or a curved segment.

Once the pullwires 80 have been adjusted to obtain a desired articulatedposition, the series of articulating members 18 may be locked in placeto hold the access sheath 10 in the desired articulated position. Suchlocking is achieved by holding most or all of the pullwires 80simultaneously to force each articulating member 18 against itsneighboring member 18. Locking strength is dependent on a number ofvariables including shape, material, and surface texture of thearticulating members 18. As shown in FIGS. 6A and 6B, the interiorshapes of bases 88 and domes 86 are selected to provide the desiredstrength of locking, degree of articulation, smoothness of movement, andsteerability of access sheath 10. As shown in FIG. 6A, a sloping innersurface 90 may be formed on the interior of the domed ring 84. As shownin FIG. 6B, a stepped inner surface 92 may be present on the interior ofthe domed ring 84. In some cases, the stepped inner surface 92 providesa greater ability to lock tightly, however this may compromisesmoothness in steering. As shown in FIG. 6C, a domed inner surface 93may be present on the interior of the domed ring 84. To increase thelocking ability, outer surfaces of the dome 86 and/or the inner surfaces90, 92, 93 of the base 88 may be textured or coated with materials toincrease friction, or a frictional layer may be applied to each dome 86or a frictional spacer may be positioned between domed rings 84. Whenthe domed rings 84 comprise a metal such as stainless steel, the rings84 may be sandblasted to increase surface roughness. Alternatively asandpaper or a steel brush may also be used to increase roughness, orthe surfaces may be sintered or have grooves or bumps. When the domedrings 84 comprise an injection molded polymer, a desired roughness maybe molded into the surfaces or machined or applied after molding.

A variety of articulation mechanisms can be used to articulate theaccess sheath. In preferred embodiments, pullwires 80 are used. Anynumber of pullwires 80 may be used to articulate the access sheath 10.FIGS. 7A-7D illustrate an embodiment of an articulating member 18 whichaccommodates such pullwires 80. FIG. 7A is a cross-sectional view of thebase 88 of the articulating member 18. Four pullwire lumens 82 are shownequally spaced throughout the wall of the base 88. Such spacing allowscurvature of the articulating members in each of the four directions. Itmay be appreciated that any spacing may be achieved between the pullwirelumens 82 to provide curvature in any desired direction. FIGS. 7B-7C areside views of the member 18 wherein the pullwire lumen 82 is shown topass through the wall of the base 88 and part of the wall of the dome86. In this example, the sloping inner surface 90 is shown, however, itmay be appreciated that any inner surface contour may be used. FIG. 7Bis a perspective view of the articulating member 18 illustrating allfour pullwire lumens 82 passing through the base 88 and partiallythrough the dome 86.

Similarly, FIGS. 8A-8D illustrate an embodiment accommodating eightpullwires. FIG. 8A is a cross-sectional view of the base 88 of thearticulating member 18. Eight pullwire lumens 82 are shown equallyspaced throughout the circumference of the wall of the base 88. Suchnumber and arrangement of pullwires provides even greater control of thecurvature of the access sheath than the embodiment having fourpullwires. Again, the lumens may be spaced, sized and arranged toprovide any desired curvature. FIGS. 8B-8C are side views of thearticulating member 18 having eight pullwire lumens 82. As shown, thepullwire lumens 82 pass through the base 88 and partially through thedome 86. This embodiment also illustrates a sloping inner surface 90.However, it may be appreciated that any type of inner surface may beused, whether it be stepped, tapered, domed, balled or some combinationthereof. Similarly, FIGS. 9A-9D illustrate views of an embodiment of theaccess sheath 10 that includes eight pullwire lumens 82. However, inthis case the embodiment shows a stepped inner surface 92 particularlyvisible in FIGS. 9B-9C.

FIGS. 10A-10E illustrate an embodiment of an articulating member 18which is designed to reduce any possible binding of the pullwires and toincrease stability of curves during articulation. To reduce binding ofthe pullwires during articulation, oblong pullwire lumens 83 are used.As shown in FIG. 10A, a cross-sectional view of the base 88 of thearticulating member 18, four circular pullwire lumens 82 are presentalong with four oblong pullwire lumens 83. The lumens 82, 83 are shownequally spaced and alternating throughout the wall of the base 88. Suchspacing allows curvature of the articulating members in each of the fourdirections. The oblong pullwire lumens 83 allows the pullwires to shiftor slide along the lumen 83 to provide more gradual, smoother pathwaysfor the pullwires to follow through the articulating members 18. Oblongpull wire lumens 83 may be of oval, elliptical, arcuate, or a roundedrectangular shape in cross-section, with a length in the circumferentialdirection substantially longer than the width in the radial direction,usually being at least 1.5 times as long, preferably at least twice aslong and in some embodiments at least 3 times as long, and may subtendan arc of at least about 5 degrees, and preferably at least about 20degrees along the circumference of member 18. FIG. 10 B is a side viewof the member 18 wherein the circular pullwire lumen 82 is shown to passthrough the wall of the base 88 and part of the wall of the dome 86 andthe oblong pullwire lumens 83 are shown on either side of the circularpullwire lumen 82. In a preferred embodiment, circular pullwire lumens82 alternate with oblong pullwire lumens 83 around the circumference ofmember 18. In this embodiment, dome 86 preferably is divided into aseries of annular sections separated by channels in the outer surfacethereof, such that contact between adjacent members 18 is limited to theouter surfaces of the annular sections. Some or all of the channels maybe axially aligned with oblong pullwire lumens 83. The annular sectionsof domes 86 preferably subtend an angle of between about 10 and 80degrees, preferably between about 20 and 45 degrees, along thecircumference of members 18.

To increase stability of the curves during articulation, pins are usedto keep the members 18 aligned, as illustrated in FIGS. 10C-10E. Asshown in FIG. 10C, at least one hole 89 is formed in the wall of thedome 86 and a notch 91 is formed in the base 88. FIG. 10D provides aperspective view of such a hole 89 and notch 91 in the member 18.Typically, as shown, the holes 89 and notches 91 are formed in pairs onopposite sides of the member 18. Referring now to FIG. 10E, pins 93 areinserted into holes 89 and soldered in place. Such pins 93 are typicallystainless steel and may have an outer diameter of approximately 0.020in. and length of approximately 0.030 in. When the members 18 areassembled and interlocked as shown, the notches 91 receive the pins 93.Thus, during articulation, the movement of members 18 is limited torotation about an axis drawn through pins 93. This stabilizes the deviceand reduces any rotation in undesired directions.

Liners

Referring to FIG. 11A, the access sheath 10 may further comprise variousliners which extend through the lumens of the articulating members 18.As shown, a braid 104 may extend through the central lumen 16 of theshaft 11. Such a braid may be comprised of stainless steel or anyappropriate material. Typically the braid 104 extends through a lengthof the shaft 11 to the articulating members 18. The braid 104 providesrigidity and torque response of the shaft 11, proximal to thearticulating members 18. Therefore, the braid 104 does not extend withinthe articulating members 18. Instead, an outer liner 102 and inner liner100, supported by a coil 101 or similar structure therebetween, extendthroughout the length of the articulating members 18. Typically, thecoil 101 is comprised of stainless steel or similar material. In someembodiments, the outer liner 102 comprises 35D PEBAX, PTFE, urethane,nylon or polyethylene, to name a few. However, any suitable polymer maybe used. Also, in some embodiments, the inner liner 100 is comprised ofPTFE or a similar low friction material. Such liners 100, 102 allow aninterventional device 70 to be passed through the central lumen 16without interference with the articulating members 18. In addition,pullwire lumen liners 106 may extend through the pullwire lumens 102 andencapsulate the pullwires 80. Such pullwire lumen liners 106 may becomprised of a braided polyimide or any suitable material to providestrength, flexibility, and protection of the pullwires 80. Finally, insome embodiments, an external liner 105 is positioned over thearticulating members and is fused to the inner liner 100 and outer liner102 at the distal tip. Such an external liner 105 may be comprised ofany suitable material, such as PEBAX 35D, and is generally forprotection and continuity of the articulating members and as a bloodbarrier.

Articulation

As described previously, the pullwires 80 pass through the articulatingmembers 18 and attach to the shaft 11 at various attachment points.Referring to FIG. 11B, a first pullwire 120 is shown fixedly attached tothe shaft 11 at a primary attachment point 122. Applying tension to thefirst pullwire 120 arcs the series of articulation members 18 proximalto the primary attachment point 122 to form a primary curve 40. In thisexample, the primary attachment point 122 is shown midway along theseries of articulating members 18. This provides a primary curve 40proximal to this point 122. It may be appreciated that the primaryattachment point 122 may be located anywhere along the shaft 11,including at the distal tip 15. When attached to the distal tip 15,applying tension to the first pullwire 120 would create a primary curve140 across the entire section of articulating members 18.

In the example illustrated in FIG. 11B, a second pullwire 124 is shownfixedly attached to the shaft 11 at a secondary attachment point 126.Applying tension to the second pullwire 124 arcs the series ofarticulating members 18 proximal to the secondary attachment point 126to form a secondary curve 46. Since the first pullwire 120 has alreadycreated a primary curve 140 in the proximal section, pulling on thesecond pullwire 124 creates a secondary curve in a section distal to theproximal section.

Further, a third pullwire 128 may be present which is fixedly attachedto the shaft 11 at a distal attachment point 130 so that pulling thethird pullwire 128 moves the distal end through an angle theta 50 (seeFIG. 4B). Thus, shaft 11, having pullwires 120, 124, 128 which terminateat multiple attachment points 122, 126, 130, respectively, allow theaccess sheath 10 to be capable of forming a multitude of curves inseveral different planes.

Access System

Referring to FIG. 12, an embodiment of an access system 148 of thepresent invention is illustrated. The access system 148 comprises anaccess sheath 150 including a shaft 151 having a proximal end 152, adistal end 154, and a central lumen 156 therethrough. The distal end 154is sized to be passable through a body lumen to a body cavity.Therefore, the distal end 14 preferably has an outer diameter in therange of approximately 0.040 in. to 0.500 in., more preferably in therange of 0.130 in. to 0.300 in. In addition, a portion of the sheath 150is comprised of a series of articulating members 158. In thisembodiment, the articulating members 158 are shown disposed at thedistal end 154 of the sheath 150, terminating in a distal tip 155.However, it may be appreciated that the articulating members 158 may bedisposed at any location along the sheath. For example, if a straight ornon-articulating portion is desired near the distal end 154, thearticulating members 158 may be located at a more proximal position.Further, portions of the sheath having articulating members 158 may beinterspersed with non-articulating portions, such as in an alternatingpattern. A handle 160 is mounted to the proximal end 152 of sheath 150.The access system 148 further comprises an obturator 168 sized forpassage through the central lumen 156, as shown. The obturator 168preferably has an outer diameter in the range of approximately 0.025 in.to 0.440 in., more preferably in the range of 0.115 in. to 0.240 in.Usually, a hemostasis valve of well-known construction (not shown) willbe mounted to or within handle 160 in communication with central lumen156 that allows obturator 168 to be inserted into and removed fromcentral lumen 156 without loss of blood. Obturator 168 may have an axiallumen 169 through which a guidewire GW may be slidably inserted tofacilitate guiding access system 148 through the vasculature. If such aguidewire lumen is present, obturator 168 will usually also include ahemostasis valve HV mounted to handle 170 in communication with theguidewire lumen to allow obturator 168 to be slidably introduced overguidewire GW and to allow guidewire GW to be removed from lumen 169without loss of blood. Guidewire GW, which may be any of variouscommercially available guidewires, may optionally be included in thesystem and kits of the invention.

The articulating members 158 of the access sheath 150 may be the same orsimilar to the articulating members 18 of the articulatable accesssheath 10. As mentioned, the articulating members may have any shape,particularly a shape which allows interfitting or nesting as shown inFIG. 5. In addition, pullwires may be present which pass through thearticulating members 158 in a manner similar to the pullwire 80illustrated in FIG. 5. However, the pullwires are not used to positionthe articulating members 158.

The portion of the sheath 150 having the articulating members 158 ismovable into an articulated position by action of the obturator 168 orother device which can fit within the central lumen 156. Once theobturator 168 has been placed within the central lumen 156 of the sheath150, as shown, the obturator 168 can be moved into any configuration.For example, the obturator 168 can be shaped to have bends, arcs, curvesor angles which in turn applies the same configuration to thesurrounding sheath 150. Shaping of the obturator 168 can be achieved byany suitable mechanism, such as pullwires which extend through theobturator 158 and can be manipulated in a manner similar to thearticulatable access sheath 10. Thus, the sheath 150 and obturator 168can be moved into articulated positions similar to those shown in FIGS.2A-2D.

Actuation of the positioning mechanisms is achieved with the use ofactuators, such as actuators 170, 172, 174 located on an obturatorhandle 176. The obturator handle 176 may be connectable to a handle 160of the sheath 150 at a connection joint 178. The actuators 170, 172, 173are used to bend, arc or reshape the obturator 168 underlying theportion of the sheath 150 comprising articulating members 158. Forexample, a primary curve actuator 170 can be used to actuate one or morepull wires to form a primary curve in the portion of the sheath 150comprising the series of articulating members 158. Further, a secondarycurve actuator 172 can be actuated to form a secondary curve in theportion of the sheath 150 comprising the series of actuating members158. And a theta actuator 174 can be manipulated to move the distal tip155 through an angle theta.

Once the sheath 150 is in the desired configuration, a locking actuator180 on the handle 160 may be used to actuate a locking mechanism to lockthe articulating members 158 in the articulated position. Optionally,the obturator 168 may also be locked in place by an obturator lockingmechanism actuated by an obturator locking actuator 186. Typically, theobturator 168 would be locked in place prior to the sheath 150 to holdthe sheath in the desired orientation. Once the sheath 150 is thenlocked, the obturator 168 may be unlocked and removed. Again, it may beappreciated that such actuators 170, 172, 174, 180, 186 and anyadditional actuators located on the handles 160, 176 may take anysuitable form including knobs, buttons, levers, switches, toggles,sensors or other devices. In addition, the handles 160, 176 may includea numerical or graphical display of information such as data indicatingthe articulated position of the sheath 150 and/or obturator 168.

FIGS. 13A-13D illustrate a method of using the access system 148 foraccessing the mitral valve MV. To gain access to the mitral valve, theaccess system 148 may be tracked from a puncture in the femoral vein,through the interior vena cava and into the right atrium. This may befacilitated by the use of a guidewire that is first inserted through thevasculature into the heart, and sheath 150 and obturator 168 are thenslidably introduced over the guidewire. Preferably, obturator 168 willhave a guidewire lumen for this purpose as described above. As shown inFIG. 13A, the access system 148 is then punctured through a fossa F inthe intra-atrial septum S. Obturator 168 may further have a distal tipconfigured to penetrate the inter-atrial septum S, or obturator 168 maybe removed and a separate penetration tool may be inserted though theaccess sheath 150. Alternatively, if a guidewire is used, the guidewiremay have a tip suitable for penetrating the inter-atrial septum and thedistal tip of obturator 168 may be tapered to facilitate widening theguidewire penetration so as to allow passage of sheath 150. The system148 is then advanced through the fossa F so that the distal tip 155 isdirected over the mitral valve MV. Again, it may be appreciated thatthis approach serves merely as an example and other approaches may beused, such as through the jugular vein, femoral artery, port access ordirect access, to name a few. It may also be appreciated that the sheath150 and obturator 168 of the system 148 may alternatively be advanced inseparate steps.

It is then desired to move and tip the distal tip 155 so that thecentral lumen 156 is directed toward the target tissue, the mitral valveMV. In particular, the central lumen 156 is to be directed toward aspecific area of the mitral valve MV, such as toward the opening 60between the valve leaflets LF, so that a particular interventionalprocedure may be performed. A primary curve 200 may be formed due toactuation of the obturator 168, as described above. The obturator 168applies forces to the central lumen 156 to reposition the articulatingmembers 158. In this example, formation of the primary curve 200 movesthe distal tip 155 within a primary plane, corresponding to previousplane X in FIG. 2A, parallel to the valve surface. This moves the distaltip 155 laterally along the short axis of the mitral valve MV, andallows the distal tip 155 to be centered over the opening 60. In thisarticulated position, any interventional devices which are passedthrough the central lumen 16 would be directed horizontally over thevalve MV. To direct catheters or tools into the opening 60, it isnecessary that the distal tip 155 is pointed downward towards the mitralvalve MV.

Referring to FIG. 13B, the access sheath 150 is shown in an articulatedposition which includes a secondary curve 202 in a secondary plane,corresponding to previous plane Z in FIG. 2B. Formation of the secondarycurve 202 moves the distal tip 15 vertically and angularly between thecommissures C, directing the central lumen 156 toward the mitral valveMV. In this articulated position an interventional device which ispassed through the central lumen 156 would be directed toward and/orthrough the opening 60. Although the primary curve 200 and the secondarycurve 202 may be varied to accommodate different anatomical positions ofthe valve MV and different surgical procedures, further adjustment maybe desired beyond these two curvatures for proper positioning of theaccess sheath 150.

Thus, the access sheath 150 may include additional curvatures throughoutthe articulating members 158 and/or allow the distal tip 155 to moveangularly through an angle theta 204 by action of the obturator 168.This moves the tip 155 vertically and angularly through a theta plane,corresponding to previous plane Y in FIG. 2C-2D. Movement of the distaltip 155 through the angle theta 50 in either direction is shown indashed line in FIG. 13B. Consequently, the central lumen 156 can bedirected toward the mitral valve MV within a plane which differs fromthe secondary plane. After such movements, the access sheath 150 will bein an articulated position which positions the distal tip 15 so that theopening of the central lumen 156 at the tip 155 faces the desireddirection. Once the desired articulated position is achieved, thearticulating members 158 are then locked in place by a locking feature,such as by activation of a locking mechanism.

Referring to FIG. 13C, the obturator 168 is then removed while thesheath 150 remains in the articulated position. The locked access sheath150 allows for the passage of interventional devices 70, as illustratedin FIG. 13D. The interventional device 70 can be passed through thecentral lumen 156 toward the target tissue, in this case the mitralvalve MV. Positioning of the distal end 155 over the opening 60, asdescribed above, allows the device 70 to pass through the opening 60between the leaflets LF if desired, as shown. At this point, any desiredsurgical procedure may be applied to the mitral valve for correction ofregurgitation or any other disorder. In a preferred method, the mitralvalve is repaired using a “bow-tie” or “edge-to-edge” technique withdevices introduced through the access sheath of the invention. Suitabledevices and techniques are described in copending U.S. patentapplication Ser. No. 10/441,531 (Attorney Docket No. 020489-001400US),U.S. patent application Ser. No. 10/441,508 (Attorney Docket No.020489-001500US), and U.S. patent application Ser. No. 10/441,687(Attorney Docket No. 020489-001700US), filed on the same day as thepresent application, which have been incorporated herein by reference.Other procedures that may be performed using devices introduced throughthe access sheath of the invention include ablation of the pulmonaryveins for treatment of atrial fibrillation, mapping and ablation ofother regions in or on the heart, annuloplasty of the mitral valve,repair of other heart valves, repair of septal defects, and otherdiagnostic and therapeutic procedures in the heart. The access sheath ofthe invention is further suitable for accessing and performingprocedures on other organs of the body either intraluminally or viasurgical penetrations, including stomach, intestines, bowel, bladder,lungs, liver, gall bladder, uterus, and others.

It may be appreciated that in some embodiments both the obturator 168and the sheath 150 are independently steerable. In these embodiments,the obturator 168 and sheath 150 can be shaped or articulated by anysuitable mechanism, such as pullwires which extend through the obturator158 and separate pullwires which extend through the sheath 150 and canbe manipulated to create bends, arcs, curves or angles. Thus, the sheath150 and obturator 168 can be moved into articulated positions similar tothose shown in FIGS. 2A-2D.

Referring now to FIG. 14, kits 300 according to the present inventioncomprise any of the components described in relation to the presentinvention. In some embodiments, the kit 300 comprises an articulatableaccess sheath and instructions for use IFU. In other embodiments, thekit 300 comprises an access sheath 150, an articulatable obturator 168and instructions for use IFU. Optionally, any of the kits may furtherinclude any of the other system components described above, such as aninterventional device 70, or components associated with positioning adevice in a body lumen, such as a guidewire 302 or needle 304. Theinstructions for use IFU will set forth any of the methods as describedabove, and all kit components will usually be packaged together in apouch 305 or other conventional medical device packaging. Usually, thosekit components which will be used in performing the procedure on thepatient will be sterilized and maintained within the kit. Optionally,separate pouches, bags, trays or other packaging may be provided withina larger package, where the smaller packs may be opened separately toseparately maintain the components in a sterile fashion.

Although the foregoing invention has been described in some detail byway of illustration and example, for purposes of clarity ofunderstanding, it will be obvious that various alternatives,modifications and equivalents may be used and the above descriptionshould not be taken as limiting in scope of the invention which isdefined by the appended claims.

1. An articulatable access system for accessing a body cavitycomprising: a shaft having a proximal end, a distal end, and a centrallumen therethrough, the central lumen having proximal and distalopenings, wherein a portion of the shaft comprises a series ofarticulating members defining a distal region near the distal end, aproximal region proximal to the distal region, and a middle regiontherebetween, wherein the distal end is passable through to the bodycavity and wherein the central lumen and the distal opening are sizedfor passage of an interventional device therethrough; a first set ofpullwires operably coupled with the proximal region at a primaryattachment location such that applying tension to the first set ofpullwires deflects the articulating members to form a primary curveproximal to the primary attachment location, the primary curve having afirst radius; a second set of pullwires operably coupled with the middleregion at a secondary attachment location such that applying tension tothe second set of pullwires deflects the articulating members to form asecondary curve proximal to the secondary attachment location, thesecondary curve distal to the primary curve and having a secondaryradius different than the first radius; a third set of pullwiresoperably coupled with the distal region at a distal attachment locationsuch that applying tension to the third set of pullwires moves thedistal end of the shaft through an angle theta, wherein at least some ofthe pullwires extend through one or more pullwire lumens disposed in oneor more of the articulating members, at least some of the pullwirelumens being oblong and adapted to reduce binding of the pullwirepassing therethrough, the oblong pullwire lumens having a length in thecircumferential direction substantially longer than a width in theradial direction; and an obturator removably positionable in the centrallumen and configured to position the portion of the shaft in a firstshape.
 2. An articulatable access system as in claim 1, furthercomprising a locking mechanism to hold the articulating members in afixed articulated position to direct the device to the body cavity. 3.An articulatable access system as in claim 1, wherein the primary curvehas a radius of curvature in the range of approximately 0.125 inches to1.000 inches.
 4. An articulatable access system as in claim 1, whereinthe secondary curve has a radius of curvature in the range ofapproximately 0.050 inches to 0.750 inches.
 5. An articulatable accesssystem as in claim 1, wherein the primary curve and secondary curve liein different planes.
 6. An articulatable access system as in claim 5,wherein the primary curve and secondary curve lie in substantiallyorthogonal planes.
 7. An articulatable access system as in claim 1,wherein the distal region terminates in a distal tip and the third setof pullwires is fixedly attached to the distal tip to allow the distaltip to move through an angle theta.
 8. An articulatable access system asin claim 7, wherein the secondary curve and the angle theta lie indifferent planes.
 9. An articulatable access system as in claim 8,wherein the secondary curve and the angle theta lie in orthogonalplanes.
 10. An articulatable access system as in claim 7, wherein theprimary curve, secondary curve and the angle theta each lie in differentplanes.
 11. An articulatable access system as in claim 10, wherein theprimary curve, secondary curve and the angle theta each lie inorthogonal planes.
 12. An articulatable access system as in claim 1,wherein distal end is configured to be passable through a blood vesselto the body cavity.
 13. An articulatable access system as in claim 12,wherein the body cavity comprises a chamber of a heart and thearticulated position directs the central lumen toward a valve.
 14. Anarticulatable access system as in claim 1, wherein the obturator isgenerally straight such that the first shape is generally straight. 15.An articulatable access system as in claim 1, wherein the obturator isarticulatable such that the first shape has at least one curve.
 16. Anarticulatable access system as in claim 1, wherein the obturator isflexible such that the shaft is positionable through the patient'svasculature when the obturator is positioned in the central lumen. 17.An articulatable access system as in claim 1, wherein the first set ofpullwires comprises a pair of pullwires operably coupled with thearticulating members.
 18. An articulatable access system as in claim 1,wherein the second set of pullwires comprises a pair of pullwiresoperably coupled with the articulating members.
 19. An articulatableaccess system as in claim 1, wherein the third set of pullwirescomprises a pair of pullwires operably coupled with the articulatingmembers.
 20. An articulatable access system as in claim 1, wherein thearticulating members comprise interfitting domed rings.
 21. Anarticulatable access system as in claim 1, wherein each of thearticulating members is independently rotatable against an adjacentarticulating members.
 22. An articulatable access system as in claim 1,wherein the angle theta is in the range of −000 to +100° degrees.
 23. Anarticulatable access system as in claim 2, wherein the locking mechanismcomprises means for holding at least one of the pullwires in a tensionedposition so that the articulating members are compressed together. 24.An articulatable access system as in claim 2, wherein the lockingmechanism comprises a frictional surface on at least a portion of thearticulating members to enhance friction between the articulatingmembers.
 25. An articulatable access system as in claim 1, wherein theobturator further comprises a guidewire lumen configured to slidablyreceive a guidewire.
 26. An articulatable access system as in claim 1,further comprising a hemostasis valve in communication with the centrallumen adapted for inhibiting fluid flow therefrom, the hemostasis valvebeing configured to receive the interventional device and the obturator.